GB 10035-2017

Active

Air-bag type sequential external counter-pulsation device

气囊式体外反搏装置

Standard Type
GB
ICS
11.040.40
CCS
C45
Status
Active
Issue Date
2017-12-29
Implementation
2019-07-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the technical requirements, test methods, inspection rules, and marking/packaging for air-bag type sequential external counter-pulsation devices used in clinical treatment. It applies to medical devices that improve blood circulation by sequentially inflating air bags wrapped around the patient's lower limbs, primarily for treating ischemic cardiovascular and cerebrovascular diseases. The standard ensures safety and performance consistency for these devices in hospital settings.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.